Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud’s syndrome, diabetic arteriopathy and acrocyanosis).
The capsules should be administered with a sufficient amount of water (one glass) during or after food.
Peripheral vasular disorders: One or two 100mg capsules three times daily for a minimum of three months, or at the discretion of the physician.
In patients with renal impairment a dose adjustment may be considered.
The safety and efficacy of naftidrofuryl in the paediatric population have not been established. This drug is not indicated for use in children.
For oral use (swallowing).
Depression of cardiac conduction and convulsions may occur.
The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed with diazepam.
Two years from the date of manufacture.
Shelf-life after dilution/reconstitution: Not applicable.
Shelf-life after first opening: Not applicable.
Store below 25°C in a dry place.
Protect from light.
The product containers are rigid injection moulded polypropylene containers with snap-on polyethylene lids.
The product may also be supplied in blister packs in cartons:
a) Carton: Printed carton manufactured from white folding box board.
b) Blister pack: (i) 250µm white rigid PVC/PVdC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.
Pack sizes:
Al/PVC/PVDC: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s
PP Tablet Container: 100s, 250s, 500s, 1000s
Not applicable.
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